4. A Drug Safety Monitoring Board (SMB). The duty of the SMB is to provide recommendations to the PI regarding medication issues and premature termination of the study for safety reasons. The SMB will be responsible for the quarterly review of data related to adverse clinical experiences and to assure that safety standards are maintained throughout the clinical trial. Three clinician-scientists, knowledgeable in the performance of clinical trials, members of the full time faculty at the adjacent Kennedy Krieger Institute, and not under the influence of the Johns Hopkins Director of Pediatric Neurology, will serve on the Board: Pediatric neurologists Dr's Gerald Raymond and Sakku Naidu and Dr Bruce Shapiro, a neurodevelopmental pediatrician.